Partial versus complete thymus removal during infant heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, interventional, single-center study at Nantes University Hospital comparing immune outcomes after partial versus complete thymectomy in infants undergoing cardiac surgery before 6 months of age. Seventy infants are enrolled non-randomly into three groups: complete thymectomy during cardiopulmonary bypass, partial thymectomy during cardiopulmonary bypass, and a control group undergoing cardiac or non-cardiac surgery without thymectomy. Blood samples are collected at the time of surgery and at 12 months postoperatively to measure T-cell counts, maturation markers, and immunological function, and clinical infection rates are tracked. The study aims to see if partial thymectomy better preserves cellular immunity and reduces infection risk compared with total thymus removal.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- Children aged between 0 and 6 months;
* Born at a gestational age \> 37 weeks' gestation;
* With an indication for cardiac surgery under CEC at Nantes University Hospital;
* Cardiopediatric follow-up planned at Nantes University Hospital;
* Written agreement signed by legal guardians to participate in the study.

For the control groups:

* Control group A (cardiac surgery without thymectomy):

  * Children aged between 0 and 6 months of age;
  * Born at a gestational age \> 37 SA;
  * Indicated for thoracotomy cardiac surgery at Nantes University Hospital;
  * Cardiopediatric follow-up planned at Nantes University Hospital;
  * Written agreement signed by legal guardians to participate in the study.
* Control group B (non-cardiac surgery)

  * Children aged between 0 and 6 months;
  * Born at a gestational age \> 37 SA;
  * Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital);
  * Planned follow-up surgery at Nantes University Hospital;
  * Written agreement signed by legal guardians to participate in the study.

Exclusion Criteria :

* Gestational age \< 37 SA;
* With a history of cardiac surgery under ECG;
* And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
* And/or a history of partial or complete thymectomy;
* Receiving long-term immunosuppressive treatment;
* Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;
* parental refusal.

Exclusion Criteria:

* \- Gestational age \< 37 SA;
* With a history of cardiac surgery under ECG;
* And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
* And/or a history of partial or complete thymectomy;
* Receiving long-term immunosuppressive treatment;
* Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;
* parental refusal.

Where it's running

• Chu de Nantes
  Nantes, France Recruiting
• CHU de Nantes
  Nantes, France Not yet recruiting

Study contacts

• Principal investigator: Alexis Chenouard, PH — Nantes University Hospital
• Study coordinator: Alexis Chenouard, PH
• Email: alexis.chenouard@chu-nantes.fr
• Phone: 02 44 76 82 21

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.